News

NEW YORK–Izun Pharmaceuticals Corporation (“Izun”, “Company”, izunpharma.com), a clinical-stage company focused on developing high efficacy products based on pharmaceutically active compounds derived from botanical sources announced today that the results from a recently completed double-blind, Phase 2 clinical study in oral mucositis indicated promising positive outcomes for the investigational product IZN-6N4.

The study was conducted at 12 centers in the United States and Israel. The trial enrolled a total of 110 patients with head and neck cancer who were scheduled to receive standard regimens of concomitant chemoradiation. Not only did patients treated with IZN-6N4 have less mouth and throat pain and soreness than controls, but importantly, they were also more able to maintain their weights throughout the course of radiotherapy. The data supports that the best efficacy of IZN-6N4 was related to its initiation of use at the start of chemoradiation.

Jack V. Talley, Chief Executive Officer of Izun Pharmaceuticals commented, “We are pleased with the outcome of this study. The results point toward utility in a large cancer patient population for which there are few, if any, approved therapeutic alternatives. The FDA has approved a prior product based on symptomatic improvement in oral mucositis patients. We plan to meet with the FDA as soon as possible to chart the next steps in the development of IZN-6N4.”

“Oral mucositis is a dominant, painful toxicity of radiation therapy in patients being treated for head and neck cancer,” said Dr. Stephen Sonis, an expert in the field and an advisor to the Company. Sonis continued, “IZN-6N4’s successful mitigation of symptoms bodes well for a new treatment option which will ease the burden of mucositis.”

About Izun Pharmaceuticals

Izun Pharmaceuticals is a US based clinical stage pharmaceutical company with a wholly owned R&D center in Israel. Izun’s technology platform allows it to develop botanical drugs by optimizing and purifying the extracted botanical compounds to yield polymolecular drug candidates. These patented products are designed to impact on multiple specific receptor targets. The main therapeutic focus is on agents that can reduce inflammation and accelerate healing. Izun is currently active in developing therapeutic products for a number of indications including: oral care, oncology support, wound care, women’s health care, gastrointestinal disease and dermatologic conditions. Izun uses the inherent advantage of the natural botanical sources to deliver robust clinical results with an excellent safety profile. Izun has received approval for a number of oral care products that are marketed.

Izun Disclosure Notice: This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein or which are otherwise made by or on behalf of the Company that are not statements of historical facts may be deemed forward looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “to,” “plan,” “expect,” “believe,” “anticipate,” “intend,” “could,” “should,” “would,” “estimate,” or “continue,” or the negative or other variations thereof or comparable terminology are intended to identify forward looking statements. Investors are cautioned that all forward looking statements involve risk and uncertainties which may cause results to differ materially from those set forth in the statements. Such risks and uncertainties include, but are not limited to the following: the success of research and development activities and the speed with which regulatory authorizations and product launches may be achieved; government regulation generally; competitive developments; the ability to successfully market products domestically and internationally; difficulties or delays in manufacturing or issues relating to manufacturing capacity; commercial obstacles to the successful introduction of brand products generally; legal defense costs, insurance expenses, settlement costs, and the risk of an adverse decision or settlement relating to product liability, patent protection, governmental investigations, and other legal proceedings; the Company’s ability to acquire and protect patents and other intellectual property both domestically and internationally; the absence of certainty regarding the receipt of required regulatory approval or the timing or terms of such approvals; any changes in business, political and economic conditions; business interruption due to hurricanes or other events outside of the Company’s control.

Investors are cautioned not to place reliance on these forward looking statements, which are valid only as of the date they were made. The Company undertakes no obligation to update or revise any forward looking statements to reflect new information or the occurrence of unanticipated events or otherwise, except as expressly required by law.

New York, N.Y. – Izun Pharmaceuticals Corporation (“Izun”, “Company”, izunpharma.com), a clinical stage company focused on developing high efficacy products based on pharmaceutical compounds derived from botanical sources announced today that the FDA has approved the Company’s 510(k) application for Curasite Wound Care Hydrogel. Curasite is a proprietary topical combination of three botanical extracts: Centella asiatica, Echinacea purpurea and Sambucus nigra in a hydrogel base. The prescription indications approved for use include the treatment of:

Mechanistically, in part, Curasite™ with its hydrogel base and botanical ingredients increases the moisture content within and around the wound by donating water, which makes the product effective in protecting the wound and in assisting the debridement and desloughing process in dry necrotic wounds, while maintaining a moist wound environment for optimal wound healing.

Curasite™ was developed using Izun’s proprietary botanical technology, which has been studied in over 600 patients in an array of clinical trials in the United States and abroad. Curasite™ is the third product approved for marketing in the United States using the Company’s technology.

It is recommended to apply Curasite™ to a cleansed wound two to three times weekly. The product can be used as long as needed provided signs of healing occur within four weeks of first application without adverse effects.

Curasite™ was approved in part due to an 82 patient, double blind, active-controlled study that was conducted over 12 weeks duration. For the first four weeks, patients with chronic diabetic foot ulcers that were present, on average, for more than 6 months, were randomized in double blind fashion to either Curasite™ or hydrogel base alone. Wound healing was evidenced beginning in week 1 in both groups but plateaued in the hydrogel base control group, whereas the Curasite™-treated group exhibited highly significant and continual progressive improvement throughout this portion of the study, reaching an average of over 50% wound closure (p < 0.0001) at 4 weeks compared to baseline.

After this 4 week double blind portion of the study, patients from both groups were then treated with Curasite™ open-label for an additional eight weeks. Patients initially administered hydrogel base who then crossed over to Curasite™ treatment began to incrementally heal their wounds. Patients in the Curasite™ group who then continued on Curasite™ for a total of 12 weeks also saw progressive improvement. For both groups the average reduction in wound size was nearly 90% at twelve weeks. More than half of patients in the follow-up portion of the study reached complete wound closure at twelve weeks of therapy.

Jack V. Talley, Chief Executive Officer of Izun commented: “We are delighted that the FDA approved our application. Diabetic foot ulcers and many of the other cited indications are poorly served by current treatment modalities. The consequences of unhealed wounds in these patient populations can be tragic. Izun is evaluating marketing partners to assist in a timely commercialization of Curasite in the United States as soon as possible”.

Izun is applying its patented proprietary, botanically-based pharmaceutical technology in several areas of unmet medical need. These include a completed single blind study to treat atrophic vaginitis. Additionally, a study for the prevention of oral mucositis in solid tumor patients receiving chemotherapy and radiation has completed enrollment and results are expected in the second quarter of 2017.

Izun Oral Care has been featured in this months issue of AGD Impact! We are proud to announce that our products were spotlighted in What’s Hot and What’s Getting Hotter. PeriActive and PerioPatch were found to be “…more effective than scaling and root planing alone and/or other over-the-counter products available.”

A study on PerioPatch is being presented at an International Symposium on Dental Hygiene in Switzerland. The study demonstrates that PerioPatch had a very significant additive benefit when used adjunctively with scaling and root planning. Pocket depths were reduced, attachment to the tooth was increased and the effect lasted until the end of the study at 3 months.

The International Symposium on Dental Hygiene (ISDH) is held every three (3) years under the auspices of the International Federation of Dental Hygienists (IFDH) to provide a forum for the understanding and discussion of issues pertaining to dental hygiene.

Symposium attendees include Dental/Oral Hygienists, Medical/Dental Practitioners, and Allied Healthcare Practitioners. The official language of the symposium is English with simultaneous translation into other languages, depending on the location.

A different association from the IFDH Association Members is voted for by the House of Delegates well in advance to host the event, under the auspices of the IFDH and the Board of Directors.

The event encompasses three IFDH elements:

Board of Directors: 2-day meeting.
House of Delegates: 2-3 day meeting for IFDH HoD members only.
Symposium: 3 days with over 1000 attendees from around the world.

These two new perio treatment options, derived from “natural substances,” offer an alternative to traditonal antimicrobials. One dentist at the School of Dental Medicine at Stony Brook has already enthusiastically incorporated them into his practice.

In the medical news, there has been significant coverage in recent years about two distinct but related medical issues: the role of inflammation in a wide range of chronic diseases (e.g., diabetes, cardiovascular disease, arthritis) and the growing recognition of the perio-systemic link (i.e., that treating oral infection and inflammation leads to improvements in overall health) (1, 2). Based on recent CDC reports that over 50% of the American adult population has significant periodontal disease, the importance of effectively treating periodontal disease cannot be underestimated (3). Then, too, there has been widespread public health concern about the overuse of antibiotics due to development of resistance as well as significant undesirable side effects. This article will focus on two new products, PeriActive and PerioPatch.

In keeping with these developments and a growing interest in health solutions from natural sources, Izun Pharmaceuticals has introduced two botanically based periodontal treatment products clinically proven to treat gingivitis and periodontitis. They are PeriActive, a daily-use mouthwash, and PerioPatch, a concentrated localized topical therapy in the form of a mucosal patch. Together they represent a breakthrough in the treatment of inflammation, as well as a welcome alternative to antimicrobials.

Unlike chlorhexidine and other rinses that kill bacteria, PeriActive is the only topical product that, in addition to reducing bacterial plaque, penetrates deep inside the gums, reducing the actual source of the disease—gingival inflammation—and repairing the damaged tissue. Its soothing film further protects and relieves associated symptoms of inflammation, including bleeding, sensitivity, and soreness. With regular use, PeriActive not only speeds the healing of gingivitis, but it also prevents more serious stages of gum disease from developing (4–6).

A more aggressive form of treatment than PeriActive, PerioPatch is especially effective for advanced stages of periodontal disease. It works rapidly to reduce inflammation and rebuild gingival tissue. It actually works “outside in,” as it is so effective that it can be placed on the outer aspect of the gingiva rather than inside the periodontal pocket. When applied to the gingiva, it generates increased collagen and clinical attachment level and reduces pocket depth (6–8). Its unique, proprietary bilayer film protects the tissue while absorbing the inflammatory exudates both from the tissue and from the gingival crevicular fluid (GCF) that would otherwise perpetuate the inflamed state. A single patch can absorb more than 140µl of GCF in 1 hour, effectively keeping the crevicular space free of inflammatory cytokines and other factors that activate the disease cycle.

These products were developed by Izun Oral Care using an extraction process that transforms natural substances into health treatments that are pharmaceutically effective. They have been proven to reduce inflammation and promote faster healing—with no adverse events—in numerous double-blind, randomized, and peer-reviewed studies at major academic centers such as Columbia University, University of North Carolina, and University of Michigan (9–11).

David W. Paquette, DMD, MPH, MMSc, associate dean, School of Dental Medicine at Stony Brook, who has a special interest in novel interventions for periodontal disease, has already incorporated PerioPatch into his patient treatment protocols. “I’m seeing some excellent results on patients that I’m treating with gingival and periodontal inflammation and irritation,” he said.

William Z. Levine, DDS, is CEO of Izun Pharmaceuticals and the director and founder of the Jerusalem Perio Center, the largest private healthcare facility specializing in the treatment of oral diseases and implantology in Israel. An active board member at several hospitals and healthcare centers in Israel, Bill received his DDS and Certificate of Periodontology at Columbia University, New York.

Periodontal disease, also known as Periodontitis, is a type of gum disease that affects the soft tissues surrounding the gums, as well as the bones that support the teeth. If left untreated, it can result in tooth loss or even worse, and can also cause other serious health problems.

If you have been diagnosed with periodontal disease, you are not alone. Statistics reveal that 80% of adults in the U.S. have had some form of Periodontitis during their lifetime. The gum disease is common, and is usually caused by poor oral hygiene.

Causes of Periodontal Disease

Every time we eat, our mouth is full of bacteria. Along with mucus and other particles, these bacteria continuously form colorless, sticky ‘plaque’ on teeth. Generally plaque forms when sugar and starch in food interact with the bacteria in our mouth. Regular brushing and flossing may remove plaque from your teeth, but it quickly re-forms. Furthermore, plaque buildup on your teeth and mineral content of your saliva can form tartar under the gumline. This not makes plaque more difficult to get rid of, but it also acts as a powerhouse of harmful bacteria. The longer the tarter and plaque remain on your teeth, the more damaging it can be.

To get rid of the bacteria and plaque in the mouth, the cells in our immune system release substances that often inflame and cause damages to the gums, alveolar bone, and periodontal ligaments. This causes swollen and bleeding gums, which is a sign of Gingivitis (the first stage of periodontal disease). Continuous inflammation causes developing pockets between the teeth and gums that fill up with bacteria, tarter and plaque. When these pockets become deep, more bacteria accumulate within them, eventually affecting the tissues and bones under your gums. In severe cases, you may also cause your teeth to loosen. This is a sign of acute Periodontitis.

In this case, you may need to seek expert advice and use PerioPatch, a topical patch designed to provide relief from the signs and symptoms of inflammation caused by Gingivitis and Periodontitis.

Some of the risk factors that may increase the chances of developing periodontal disease are:
– Smoking
– Diabetes
– Medications that tend to reduce the flow of saliva in the mouth
– Hormonal changes in the body, especially in women
– Genetic susceptibility
– Other diseases like AIDS and cancer, and their treatments can also negatively affect the health of your gums, increasing the risk of gum diseases

Symptoms of Periodontal Disease

How would you know if you have periodontal disease? Mentioned here are the common signs and symptoms of gum disease:

Periodontal disease or gum disease is an issue that is commonly faced by people around the world. If you have ever heard of anyone complaining about loose or sensitive teeth on a regular basis, high chances are that they have some form of periodontal disease.

Most forms of periodontal disease occur because of neglecting dental health. A sticky substance called plaque develops inside the mouth and is the main culprit behind gum diseases. Ignoring dental health needs can result in the buildup of plaque and tartar, which eat into the gums and leave vast pockets of space for bacteria to develop. This buildup of bacteria turns into an infection sooner or later, and that’s when you start encountering problems.

Luckily, advancements in the medical field thanks to many a pharmaceutical company in New York have made it possible to diagnose periodontal problems. Successful diagnosis involves the sufferer describing his symptoms, upon which medical professionals conduct a range of tests to determine the exact problem.

The Symptoms

There are certain symptoms that are experienced by sufferers of gum disease. However, the following symptoms may not always indicate a serious problem:

Swollen gums with a red tinge

Bleeding gums

Halitosis or bad breath

Loose and sensitive teeth

Gums recede, resulting in the teeth appearing longer

Problems experienced while chewing

Pus between gums and teeth

While the aforementioned problems don’t always indicate a serious gum disorder, you should visit a dentist as soon as you notice any of them, as periodontal disease is easier to reverse if diagnosed at an early stage.

Diagnosis

The severity of a gum disorder is diagnosed mainly through two methods. The basic purpose is to understand the amount of plaque and tartar buildup in the mouth.

Measuring Pocket Depth with an Instrument:
As plaque builds up and the resulting acid eats into the teeth and gums, pockets of space appear between the two. The pocket depth is identified with the help of a metal probe, which is inserted below the gum line. A pocket depth in the range of 1-3 mm is considered normal. However, people with pocket depths of more than 5 mm may have periodontal disease.

Dental X-Rays:
Once the pocket depth has been identified and your dentist sees it as a problem, x-rays are performed to identify any kind of bone loss. Bone loss is generally a sign of an advanced stage of periodontitis.

Classification

Gingivitis:
Recognized as the mildest form of periodontal disease, gingivitis is indicative of inflamed gum tissues. Leaving it untreated increases the risk of developing serious periodontal problems in the future. Diabetics, pregnant women, and steroid users face increased risks of developing gingivitis.

Chronic Periodontal Disease:
Once gingivitis develops into a full-blown periodontal disease, it is known as chronic periodontal disease. The gum and bone tissues worsen at a steady pace, and this is generally associated with people over the age of 40. The receding gums and teeth appearing longer are classic signs of chronic periodontal disease.

Aggressive Periodontal Disease:
With almost the same problems as chronic periodontal disease, aggressive periodontal disease involves a rapid worsening of symptoms. Loss of bone and tissue attachment is considerably faster, and this form of gum disease is associated with diabetics and smokers.

Necrotizing Periodontal Disease:
People with existing medical conditions like chronic stress, HIV, immunosuppression, and malnutrition are at risk of developing necrotizing periodontal disease, which involves tissue death and rapid destruction of bones between teeth.

Izun Pharmaceuticals is a leading pharmaceutical company in New York that has emerged in recent years with a diverse range of solutions for oral problems. Its therapies are non-steroidal, and adhere to all safety standards with regards to dental treatment.

Only people suffering from gum disease can understand, what they go through or how they suffer when bacterial infection on their gumline and areas surrounding an infected tooth reaches a critical condition. Gum diseases are really one of the most disgusting diseases people can ever have. Once you suffer from a gum disease or a periodontal disease you experience a lot of mouth irritation including swollen gums and bad breath. Apart from that depending upon the extremity or seriousness of your disease you also experience things like bleeding gums and complete tooth destruction.

That means gum diseases progress step by step and people should take their treatment seriously whenever diagnosed. One of the mildest forms of gum diseases is Gingivitis and it remain highly common among people across the world.

What is the prime cause of Gingivitis?
Bacterial plaque, which is nothing but a soft and sticky deposit found on the teeth and gums remains the only reason behind Gingivitis. If you do not maintain high oral hygiene, then this soft and sticky plaque which is formed due to bacteria living in the mouth can start infecting your gum tissues eventually resulting into Gingivitis. What actually happens is if you fail to eliminate the plaque both by brushing and flossing, it eventually results in producing poisons -which are nothing but harmful toxins that holds the potential to cause gum irritation which finally leads to Gingivitis.

Considering the fact that gingivitis is the earliest stage of gum disease, it becomes really easy for people to control it, provided the fact that they take required measures or treatment for it. Gingivitis is a stage of gum disease wherein only gum tissues are affected hence if diagnosed at the right time it can be treated effectively without doing much damage to your oral health.

The good thing is that both the bone and connective tissues which are accountable for holding the teeth in its right place remain unaffected by Gingivitis. However, if this initial stage of gum disease is left without treatment it can seriously create a huge problem for you by developing into periodontitis, which would then demand surgical procedures for its effective treatment. A periodontist is extremely dangerous for your oral hygiene as it can result in the permanent loss of your natural tooth.

PeriActive Can Reduce The Signs And Symptoms Of Gingivitis

Once you are confirmed that you are suffering from Gingivitis which is generally characterized by tender, reddened and swollen gums beside bad breath and bleeding during brushing, you should immediately start looking for its treatment.

The most important steps that you can take immediately are brushing and flossing when it comes to improving your oral hygiene and controlling Gingivitis.

In addition, to that, you can also try our product PeriActive, which is specially developed for dealing with bacterial plaque and inflammation. It’s a triple-action rinsing system that starts working quickly on minimizing the signs and symptoms of Gingivitis as soon as it’s used by the people.

It’s been effectively proved through clinical tests that PeriActive helps in controlling swollen, reddened and bleeding gums caused by Gingivitis.

Periodontal disease or gum disease, which can be defined as a progressive disease consisting of various different stages is very common among people around the world. This disease which develops step by step is characterized as having an infection of tissues answerable for supporting the gums and bone supporting the teeth. Different stages of periodontal disease are accountable for causing harm to your oral health on different levels. Yes, that’s right, the more periodontal disease progresses the more harmful it becomes for your gum tissues and teeth.

In the absence of right treatment in the initial stages, it can become slightly difficult for people to control this disease when it progresses to the advanced stages. The disease can result in tooth loss if you fail to give attention to its treatment.

According to reports, this disease remains the primary reason behind tooth loss among people across the globe.

Causes of Periodontal Disease

Periodontal disease takes place because of the oral bacteria, which remain the sole reason behind the formation of dental plaque- a soft and sticky thing found on the teeth and gums surrounding them.

Periodontal disease kicks off at a time when dangerous toxins contained in bacterial plaque begin to attack tissues across the teeth. Initially, only soft tissues surrounding the teeth are attacked by the oral bacteria. What really happens is the bacteria found in the mouth breeds quickly in the gum resulting in bacterial infection which affects the gum tissues. With the growth of the infection, the bacteria reach deep inside the gum tissues leading to gum inflammation. In such situations, the human body reacts on destroying the tissues affected by bacterial infection and that’s the reason behind receding gums.

Because of that, the pockets formed due to the bacterial infection between the teeth begins to intensify or grow. In addition, to that, the tissues accountable for forming up the jawbone also starts receding which becomes the reason for making the teeth unstable and finally the tooth loss.

Different Forms of Periodontal Disease

There are numerous types of periodontal disease and all of them need to be treated quickly in order to strengthen the affected gum tissues and to save the tooth loss.

Gingivitis

One of the most common forms of periodontal disease which are caused by the toxins found in the bacterial plaque is called Gingivitis. In this condition, the oral bacterial attacks the soft tissues which lead to swollen and bleeding gums. Apart from that bad breath and irritation causing reddened gums are other important signs of Gingivitis.

People who have the greater risk of developing this disease and may find it hard to control include people who use steroid, pregnant women, chain-smokers, and those suffering from diabetes.

Gingivitis can be easily treated by taking care of oral hygiene effectively at home which includes proper brushing and regular flossing. In addition, to that, when it comes to obtaining fast results you should opt for gum disease product like PerioPatch developed by Izun – Pharmaceutical company in New York or a professional dental cleaning.

Periodontitis

Failure of treating Gingivitis generally results in advancing the disease to a stage called Periodontitis. This happens, when bacterial colonies start to grow rapidly and the toxins produced by oral bacteria starts damaging both soft and hard gum tissues surrounding the teeth. Due to the chronic inflammation that’s is actually caused by toxins produced by bacterial plaque, both gums and teeth are destroyed badly if proper treatment is not taken.

You can control periodontal disease by following proper treatment including both surgical and non-surgical procedures.

Izun Oral Care will be at the Chicago Dental Midwinter Congress –February 25th to the 27th

The CDS Midwinter Meeting (www.cds.org) is the most important industry meeting of the years – and CDS Members attend for free! Come to the 2016 meeting and enjoy complimentary access to the Exhibit Hall featuring the latest in professional products and instruments.

You’ll get a hands-on introduction to an array of equipment and materials, meet reps for products you use, and learn about state-of-the-art advances.